Download:
pdf |
pdfPublic reporting burden for this collection of information is estimated to average 30 minutes per procedure, including the
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding
this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to:
NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0584).
Do not return the completed form to this address.
OMB#: 0925-0584
Exp. xx/xx/xxxx
Sample CICL Field Center Manual of Operations
Harvard Medical School
BRIGHAM
AND
WOMEN’S
H O S P I T A
L
Cardiac Imaging Core Lab | Brigham and Women’s Hospital
PB-A 100, 20 Shattuck Street, Boston, MA 02115, USA
Ph. 617 525 6730 | Fax. 617 582 6027
Hispanic Community Health Study – Study of
Latinos
HCHS/SOL Cohort – Visit 2
DRAFT Echocardiography Field Center
Manual of Operations
Scott D. Solomon, MD, Director
Brigham and Women’s Cardiac Imaging Core Laboratory
Boston, MA
Version: Draft 7/31/2013
CONFIDENTIALITY STATEMENT:
The information contained in this document, especially any unpublished material, is the property of Brigham and Women’s Hospital
Cardiac Imaging Core Lab and is therefore provided to you in confidence as a member of the above-referenced study staff. It is
understood that this information will not be disclosed to others without written authorization from Scott D. Solomon, MD, Director of the
Cardiac Imaging Core Lab.
DRAFT DOCUMENT – CONFIDENTIAL-
Page 1 of 29
Table of Contents
Section
Page
I.
Introduction
3
II.
Study-wide process overview
4
III.
Sonographer certification
5
IV.
Submission of Studies from the Field Center to the Reading Center
6
V.
Instructions for Electronic Transfer of Studies to the Reading Center
6
VI.
Instructions for Conducting Studies
9
VII.
Guidelines for Image Optimization
9
VIII.
Echocardiogram Protocol: Required Views
12
IX.
Detailed Review of Protocol Required Views
13
Parasternal long axis
14
Parasternal short axis
15
Apical 4 chamber
19
Apical 5 chamber
25
Apical 2 chamber
27
Apical 3 chamber
28
Subcostal view
28
X.
Reporting of Critical Results
29
XI.
Echocardiography Reading Center Contact Information
29
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 2 of 31
I. Introduction
The National Heart, Lung and Blood Institute (NHLBI) initiated the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) in
2006, with the recruitment of approximately 16,000 Hispanic/Latino adults from 4 communities across the country. In addition to being
disproportionately affected by diabetes, and the component conditions of the metabolic syndrome, Hispanics remain unfavorably
affected by health care disparities that predispose to all major adverse events. Therefore, Hispanics represent a population that is
particularly vulnerable to cardiovascular outcomes, including heart failure (HF). The performance of echocardiography at the
HCHS/SOL Visit 2 examination offers the opportunity to identify the manifestations of cardiac dysfunction that precede overt HF in the
at-risk, understudied population of Hispanic/Latino Americans. Whereas prior and predominantly cross-sectional studies have
investigated the demographic, social/culture, and clinical factors associated with HF in Hispanics/Latinos, echocardiography in
HCHS/SOL will be the first to provide comprehensive, detailed phenotyping of pre-clinical cardiac disease in a large sample of
Hispanics/Latinos with representation across age, sex, ethnic/cultural subgroups, and geographic regions.
The Brigham & Women’s Hospital Cardiac Imaging Core Laboratory (CICL) in Boston, Massachusetts will serve as the
Echocardiography Reading Center for HCHS/SOL Visit 2. This manual contains key information Field Centers need to perform high
quality study echocardiograms.
OBJECTIVES
Echocardiography
Echocardiographic examinations will be performed to estimate myocardial structure and
performance including but not limited to: left and right ventricular systolic function, left
ventricular end diastolic volume (LVEDV), left ventricular end systolic volume (LVESV), left
ventricular mass, left atrial size, LV diastolic function, mitral inflow pulsed wave Doppler (E
wave, A wave), isovolumic relaxation time (IVRT), tricuspid regurgitation (TR) velocity.
Cardiac Imaging Core Lab
To provide high quality reproducible quantitative analysis of study echocardiograms
Field Center Manual of
Operations
To instruct field centers on how to perform and send study echos to the Cardiac Imaging Core
Lab (CICL).
ROLES AND RESPONSIBILITIES
Field Centers
Perform high-quality study echocardiograms per the protocol contained in this
document
Cardiac Imaging Core Lab
Receive, review and analyze study echos.
Train and certify each field center sonographer.
Provide field centers quality feedback on echos.
Serve as a resource for sites for all echo-related questions.
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 3 of 31
II. Study-Wide Process Overview
Field centers will electronically transmit echos directly to the Cardiac Imaging Core Lab (CICL). Below is a basic diagram to describe
the study wide process that will occur.
SITE TRAINING
STUDY-WIDE PROCESS OVERVIEW
BWH
CICL
1. Hands on Sonographer Training
Field Center
2. Sonographer Certification Echo
3. Certification Feedback (Echo)
STUDY ECHOS
Weekly Reports**
Electronic Echo Transfer
Field
Center
Technical and
Non-Technical Queries
Coordinating
Center
BWH CICL
Query Responses
ANALYSIS
Long Term Media Storage
BWH CICL
Electronic Transfer of
Data
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Coordinating
Center
Page 4 of 31
III. Sonographer Certification
The purpose of certification is to ensure consistency in how echocardiograms are performed study-wide and to ensure performance of
the highest quality echocardiograms. Any sonographer who will be performing study echocardiograms must first submit two
certification studies performed in accordance with the protocol described in this manual and transferred electronically to the CICL for
review and certification.
Studies will be scrutinized for adherence to protocol, acquisition of all required views, and image quality. Itemized direct written
feedback and suggestions from the technical project manager will be provided for each study submitted. This is intended to address
any individual equipment or operator dependent problems that may arise. Sonographers will have the opportunity to re-submit a
sample protocol study should the initial submission be inadequate. Following submission of an adequate sample study, the
sonographer will be officially certified and will receive feedback documenting this.
New Field Center sonographers starting during the study period will be required undergo the certification process outlined above by
submitting 2 sample protocol studies in order to demonstrate the ability to perform a technically adequate protocol study and the
knowledge to successfully transmit this data to the CICL.
A general outline of the process is outlined below. Prior to performing and submitting a sample study for certification, the following
steps are recommended:
1.
2.
Read and review the Site Instruction Manual and Pocket Guide. An instructional video will be available on the HCHS/SOL Visit
2 Echocardiography Reading Center website as an additional resource. This is considered supplemental and is not a
requirement to receive certification. These materials will be made available on the CICL web portal for HCHS/SOL.
Contact the CICL for any questions before performing and submitting the certification echo to the CICL.
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 5 of 31
IV. Submission of Studies from the Field Center to the Reading Center
All HCHS/SOL Visit 2 echocardiograms will be transmitted electronically from Field Centers to the Echocardiography Reading Center
via a secure VPN transfer system as detailed in Section V: Instructions for Electronic Transfer of Studies to the Reading Center. Field
center staff will receive electronic confirmation (by email) upon successful receipt of each echocardiogram by the Reading Center.
Reading Center Feedback to Field Centers
The CICL will continuously monitor the adequacy and quality of all studies received according to the criteria outlined in the table below:
Criteria for Evaluating Quality of Echocardiographic Images Received from Sites
Criteria for Evaluating Image Quality
View
Parasternal long axis view
•
•
•
Apical 4 chamber view
•
•
•
Short axis at the midventricular level
•
•
•
Apical 2 chamber view
•
•
•
Doppler views
•
•
•
Scoring
2 points: Image is on axis and endocardial border well visualized in all
anatomic segments of the main structures imaged (e.g. all 4 segments of the
LV)
1 point: Image is not completely on axis, or the endocardial border is well
visualized in most but not all anatomic segments of the main structures imaged
(e.g. only 5/6 anatomic segments of the LV)
0 points: Image is completely off axis, or endocardial border not well visualized
>15% of anatomic segments of the main structures imaged
2 points: Image is on axis and endocardial border well visualized in all
anatomic segments of the main structures imaged (e.g. all 6 segments of the
LV)
1 point: Image is not completely on axis, or endocardial border is well
visualized in most but not all anatomic segments of the main structures imaged
(e.g. only 5/6 anatomic segments of the LV)
0 points: Image is completely off axis, or endocardial border not well visualized
>15% of anatomic segments of the main structures imaged (e.g. there is
dropout of ≥2 (of 6) anatomic segments of the LV)
2 points: Image is on axis and endocardial border well visualized in all
anatomic segments of the main structures imaged (e.g. all 6 segments of the
LV)
1 point: Image is not completely on axis, or endocardial border is well
visualized in most but not all anatomic segments of the main structures imaged
(e.g. only 5/6 anatomic segments of the LV)
0 points: Image is completely off axis or endocardial border not well visualized
>15% of anatomic segments of the main structures imaged (e.g. there is
dropout of ≥2 (of 6) anatomic segments of the LV)
2 points: Image is on axis and endocardial border well visualized in all
anatomic segments of the main structures imaged (e.g. all 6 segments of the
LV)
1 point: Image is not completely on axis, or endocardial border is well
visualized in most but not all anatomic segments of the main structures imaged
(e.g. only 5/6 anatomic segments of the LV)
0 points: Image is completely off axis or endocardial border not well visualized
>15% of anatomic segments of the main structures imaged (e.g. there is
dropout of ≥2 (of 6) anatomic segments of the LV)
2 points: Clear signals captured over at least 3 cardiac cycles for all Doppler
measures
1 point: Clear signals captured over at least 2 cardiac cycles for most Doppler
measures
0 points: Absent or unclear signals captured for most Doppler measures
Criteria for Scoring
Grading
Total Points
Good quality
9-10 points
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 6 of 31
Acceptable quality
6-8 points
Fair quality
4-5 points
Poor quality
≤3 points
The Field Center will receive emailed quality feedback for every echo submitted to the CICL. In situations where concerns arise
regarding the quality of a study submitted by the Field Center, the sonographer and coordinator at the specific field center will receive
additional quality feedback and recommendations from the CICL. This feedback will include technical instructions for quality
improvement. The CICL may send email queries to the Field Center in cases where additional information or clarification is needed.
Field Centers should respond to queries within 3 business days; the query will contain easy to follow instructions for the Field Centers
on how to resolve the query. Field Centers should contact the Reading Center with questions related to queries received.
V. Instructions for Electronic Transfer of Studies to the Reading Center
Echocardiograms will be transferred from Field Centers to the Reading Center electronically using secure VPN-based image transfer
technology. A dedicated workstation at each Field Center with high-speed internet capability will be set up for study transfers. Field
Centers will retain a hard copy of each echocardiogram, stored in a secure location at the Field Center.
Transfer of completed studies to the Reading Center has 2 components:
(1) Upon finalizing and closing a study on the echo machine, studies will be automatically transferred to the Field Center PC which
houses the Tomtec Image Arena software. This will act as a local temporary PACs for recent studies performed at the field center.
Image Arena will be configured to automatically forward completed studies to the CICL server via the secure VPN connection.
(2) For each Echocardiogram study performed and transmitted to the Reading Center, the sonographer must also separately submit an
electronic Echocardiography Transmittal Form (eETF) to the Reading Center as outlined below. This form provides a notification for the
Reading Center to expect the study images and provides important demographic and physiologic (heart rate, blood pressure)
information necessary in analyzing the echo studies.
1.
Sign in: Navigate to https://cicl.clinicalresearchsystems.com and sign in with your email address and password (provided to
you by the Reading Center)
2.
Initiate new ETF: Click on “New Transfer” to begin process
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 7 of 31
3.
Enter participant HCHS/SOL ID
•
4.
You will select your site identifier and enter the Subject ID. Visit will default to the only available option (‘Visit 2’)
Enter required data
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 8 of 31
•
All fields are required, and are validated according to type. If certain fields are unavailable, you can select ‘N/A’ from
the menu to the right side of that field to indicate that it is intentionally left blank.
5.
Complete transfer by clicking the ‘Complete Transfer’ button
6.
‘Transfer compete’ confirmation screen
•
You can initiate another transfer, click on “My Transfers” to view your transfer history
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 9 of 31
For questions regarding either study performance or submission, the Reading Center has an established “hot line” channel of
communication, which is listed within the Field Center Manual of Operations.
VI. Instructions for Conducting Studies
A. Echocardiographic Equipment
All echocardiograms will be performed using a dedicated ultrasound system An acquisition default for the HCHC-SOL study will be
programmed in each study echocardiography machine, incorporating the imaging parameters detailed in this section. All examinations
should be performed using the ‘HCHC-SOL’ default for subjects in sinus rhythm and the ‘HCHS/SOL AF’ default for subjects in atrial
fibrillation. All machines will also be programmed with an HCHS/SOL protocol to guide sonographers through the study protocol and
ensure that all protocol required views are obtained.
Default settings for HCHS/SOL are as follows:
2D images
H pen
Xres: ON
Elevation compounding: ON
Chroma: 1
Gray scale: 4
Persistence: low
Re-speed in the midline
Color Doppler
Map: 4
Smoothing: 3
Persistence: OFF
Spectral Doppler
Compress: 4
Reject: 4
Speed: 100 mm/sec
Default acquisition time will be 4 cardiac cycles. For patients in atrial fibrillation, select LOOP-TIME which will acquire for
5 seconds (automatic in protocol preset).
B. Subject Identification on Recorded Images
The CICL should receive no subject identifiers, such as the name, on actual echo recordings. Record only the subject’s study ID.
C. Subject Preparation
The subject’s blood pressure should be taken just prior to the echocardiogram and after the subject has been resting for 5 minutes.
Blood pressure should be performed at baseline in both arms. The highest reading should be recorded and subsequent measure
should be done on the arm with the highest reading. Be sure to record the blood pressure and initial heart rate on the electronic
Echocardiography Transmittal Form (ETF).
Fill in all of the information on the ETF including heart rate, blood pressure, height, weight, and subject date of birth.
Electrocardiographic leads (3-lead) should be placed on the subject prior to imaging. An adequate ECG signal showing a clearly
identifiable QRS complex visible on the echocardiographic monitor must be present throughout the imaging exam duration.
The subject should be placed in the steep left lateral decubitus position unless this position is not possible.
Echocardiograms should be obtained in a manner that is most consistent with good subject care. Subject care issues, including subject
comfort, should always supersede research interests. Indeed, subject cooperation and comfort are extraordinarily important in
obtaining the highest quality echocardiographic examination.
VII. Guidelines for Image Optimization
Quantitative measurements entail manually tracing the endocardium and Doppler envelopes at various periods in the cardiac cycle.
Even when images are of good quality, this can be extremely difficult, and it is therefore critically important that the best possible
endocardial definition and Doppler signal are obtained. Guidelines for obtaining optimal quality 2D, color Doppler, Spectral Doppler,
and Tissue Doppler acquisitions are outlined in this section. These general guidelines may be already accounted for in the default
HCHS/SOL echo protocols programmed in the Echo machines and are listed here for subjects who may need potential settings
modifications for image optimization.
A. General
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 10 of 31
For patients in sinus rhythm, at least four full cardiac cycles must be recorded for each protocol specified view. For subjects
in atrial fibrillation, at least ten full cardiac cycles per view must be recorded. Recording should start when the view is optimized
and end after the required number of cardiac cycles have been recorded per view.
The echocardiographic exam should be performed in the order listed in section VII: Echocardiogram Protocol: Required Views.
No measurements should be recorded on the images acquired at the Field Center. All measurements will be performed centrally at the
Echocardiography Reading Center.
B. 2D Imaging
Throughout the course of the echo exam, both imaging depth and sector width should be continuously optimized to maintain
a frame rate of 50-80 frames per second.
Ensure that the entire cardiac structure of interest is within the echo sector throughout both the systolic and diastolic periods. Optimal
visualization of endocardial borders is essential for quantitative analysis. If necessary, increase 2D gain to optimally demonstrate left
ventricular endocardial borders, particularly in the apical views. In general, tissue harmonic imaging should be used, except in the
unusual situation where this worsens endocardial border definition. Adjustment of sector width, imaging depth, 2D gain, and use of
tissue harmonic imaging from the HCHS/SOL protocol defaults may be necessary to optimize image quality and will be at the discretion
of the sonographer performing the examination.
Meticulous efforts to avoid foreshortening of imaging planes are essential to the integrity of the quantitative analysis performed on these
studies. Utilize the landmarks detailed in the following sections to ensure on axis image acquisition.
C. Color Doppler Imaging
For all color Doppler imaging, the color Doppler Nyquist limit should be at 64 cm/sec. Color Doppler gain should be set at a level just
below the level at which random background noise is seen. Neither color Doppler gain nor the Nyquist limit should be adjusted by the
sonographer from the HCHS/SOL protocol default. Color Doppler variance display will not be utilized in this examination.
For all color Doppler acquisitions, be sure to make the color Doppler sample window large enough to encompass the structure of
interest, but no larger than necessary.
D. Spectral Doppler
By the Doppler equation, velocity is inversely related to the cosine of the intercept angle between the ultrasound beam and the direction
of blood flow. Therefore, the key principle in all spectral Doppler acquisitions (both pulsed wave and continuous wave) is to optimally
align the ultrasound beam parallel to the direction of blood flow of interest. Good quality spectral Doppler tracings demonstrate clear
onset and end of flow. For pulsed wave Doppler, gain should be optimized such that a well-defined envelop is visible, with a sharp
peak and a lucent center. For both continuous and pulsed wave Doppler, sonographers will need to optimize the baseline shift and
velocity range such that the spectral envelope occupies approximately three-fourths of display. The following HCHS/SOL protocol
defaults will be set and should not be altered: (1) sweep speed 100 cm/sec, and (2) sample volume length 3mm [for pulsed wave
Doppler].
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 11 of 31
E. Tissue Doppler Imaging
Tissue Doppler imaging measures the velocity of myocardial tissue, which is low velocity and high amplitude. In contrast, the motion of
blood is high velocity and low amplitude and these signals must be filtered. For this protocol, tissue Doppler imaging will be employed
to measure annular velocities at both the mitral and tricuspid annulus (described in detail in the sections below). Like standard Doppler,
the accuracy of tissue Doppler is dependent on a parallel angle of incidence of myocardial motion with the ultrasound beam. Optimally
align the longitudinal motion of the ventricle with the ultrasound beam. Placement of the tissue Doppler sample volume appropriately at
the level of annulus (mitral or tricuspid depending on the view being obtained) is essential for high quality data and is reviewed in detail
below. Sonographers will need to optimize the baseline shift and velocity range such that the spectral envelope occupies
approximately three-fourths of display. The following HCHS/SOL protocol defaults will be set and should not be altered: (1) sweep
speed 100 cm/sec, (2) sample volume length 5mm, and (3) filter setting of 100 Hz.
Proper positioning of sample volume for mitral annular TDI:
Lateral
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Septal
Page 12 of 31
VIII. Echocardiogram Protocol: Required Measures/Views
Blood pressure
Brachial blood pressure
Measure BP at the beginning of echo examination
Echocardiographic View
Measurement
Parasternal Position
Parasternal long axis
Parasternal short axis – Aortic valve level
Parasternal short axis – LV base
Parasternal short axis – Papillary muscle
Parasternal short axis – LV apex
Apical Position
Apical 4 chamber view
Apical 4 chamber – focused on the RV
Apical 5 chamber view
Apical 2 chamber view
Apical 3 chamber view
Subcostal View
Inferior vena cava
2D imaging
Color Doppler of the mitral valve
Color Doppler of the aortic valve
2D focused imaging of the ascending aorta
2D imaging
PW and CW Doppler of the RVOT
2D imaging
2D imaging
M-mode
2D imaging
2D imaging (including LA)
Color Doppler of mitral valve/LA
Spectral Doppler (pulse wave and continuous wave) mitral flow
TDI of septal and lateral mitral annulus
2D imaging (including RA)
Color Doppler of tricuspid valve/RA
Continuous wave Doppler of tricuspid regurgitation
TDI of lateral tricuspid annulus
TAPSE of lateral tricuspid annulus
2D imaging
Pulse wave of LVOT flow
Continuous wave of transaortic flow
2D imaging (including LA)
Color Doppler MV/LA
2D imaging
2D imaging for 5-10 cardiac cycles
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 13 of 31
IX. Detailed Review of Protocol Required Views
Beginning the Exam
Complete the subject information screen on the echo machine as detailed in the figure below:
Be sure to acquire an image of this screen.
A.
Brachial Blood Pressure
Just prior to the start of the echocardiographic examination, brachial blood pressure is measured. The subject’s blood pressure should
be taken just prior to the echocardiogram and after the subject has been resting for 5 minutes. Blood pressure should be performed at
baseline in both arms. The highest reading should be recorded and subsequent measure should be done on the arm with the highest
reading. Be sure to record the blood pressure and initial heart rate on the eETF.
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 14 of 31
B. Parasternal Views
Three parasternal views will be obtained:
•
Parasternal long axis view – standard
•
Parasternal long axis view – focus on ascending aorta
•
Parasternal short axis view at 4 levels as detailed below (section B.2.)
B.1.i. Parasternal Long Axis View – Standard View
In the ideal echocardiographic “window” for the long axis:
• The LV endocardium at the septum and the posterior wall are well delineated.
• The proximal interventricular septum is horizontal and continuous with the aortic root.
• The anterior and the posterior mitral valve leaflets, and the right and noncoronary aortic valve leaflets are visible.
• The left ventricular apex is not visualized.
Avoid obtaining shortened or low parasternal views:
Grossly foreshortened PLAX View
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Low PLAX View
Page 15 of 31
B.1.ii. Parasternal Long Axis View – Focus on Ascending Aorta
•
•
•
Focus on the ascending aorta and slightly decreasing depth and adjusting focus, as needed
Optimize visualization of the aortic valve leaflets, sinuses of Valsalva, and proximal 2-4 cm of the ascending aorta
Record 1 cine loop over 3 cardiac cycles
2. Parasternal Short Axis View
Parasternal short axis view will be obtained at four levels:
1. At the aortic valve level with the RVOT and pulmonic valve visible.
2. At mitral valve when both anterior and posterior mitral valve leaflets are visualized.
3. At the mid-papillary muscle level with the papillary muscles visible.
4. At the left ventricular apex.
B.2.i. Aortic Valve Level
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 16 of 31
Acquire both 2D imaging and color Doppler of this view.
In the ideal echocardiographic “window” for the short axis at the aortic valve level:
•
•
All 3 cusps of the aortic valve are visible, with a clear upside down triangle pattern during systole.
The tricuspid valve and interatrial septum are visible.
From the parasternal short axis view at the aortic valve level, the following additional images will also be obtained:
•
PSAX view focused on the right ventricular outflow tract and pulmonic valve
•
Continuous and pulsed wave spectral Doppler of RVOT and trans-pulmonic flow
Continuous Wave Doppler through Pulmonic Valve
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 17 of 31
o
For pulse wave acquisition, ensure that the sample is in the right ventricular outflow tract (RVOT) approaching the
pulmonic valve, just prior to the level of flow acceleration and spectral broadening. Record a minimum of 3 cardiac
cycles (10 for subjects in atrial fibrillation) at a sweep speed of 100 mm/sec.
Pulse Wave Doppler in RVOT
B.2.ii. Mitral valve level, mid-papillary level, and apical level
In the ideal echocardiographic “window” for the short axis:
•
•
•
In the absence of prior infarction, the left ventricle should have a circular shape in the short axis – an elliptical shape suggests
off-axis/tangential cut through the ventricle.
Use internal LV landmarks to ensure imaging at consistent planes in the short axis: visualization of the anterior and posterior
mitral leaflets for the mitral valve level; visualization of both papillary muscles for the mid-papillary level
For all short axis images, adjust sector width and imaging depth to ensure acquisition frame rate of 50 to 70 frames per
second.
Mitral Valve Level
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 18 of 31
Mid-papillary Level
Apical Level
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 19 of 31
C. Apical Views
Five apical views will be obtained:
•
The standard apical four-chamber focused on the LV
•
The apical four-chamber dedicated to optimal imaging of the RV
•
The five-chamber view
•
The two-chamber view
•
The three-chamber view
At the Reading center, left ventricular and atrial areas and volumes will be measured from these views (i.e. using Simpson’s method).
Therefore, in all apical views, special attention should be paid to properly align the image and capture the left ventricle and atrium in full.
Avoid either foreshortening or elongating the chambers by transducer angulation.
C.1. Apical 4-Chamber View
Apical 4-Chamber
C.1.i. Focus on LV
•
Obtain 1 clip optimizing visualization of the left ventricle during systole and diastole. Obtain a second clip optimizing
visualization of the left atrium throughout systole and diastole.
o Maximize LV length and be careful not truncate the true long axis.
o The entire LV endocardium must be within the imaging sector in both end-diastole and end-systole. Pay
special attention to the apex and the lateral LV free wall, which are often the most difficult areas to visualize.
o Adjust sector width and imaging depth to ensure acquisition frame rate of 50 to 70 frames per second.
Apical 4 Chamber view, at End Systole
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Apical 4 Chamber view, at End Diastole
Page 20 of 31
•
C.1.ii. Focus on LA
Obtain 1 clip optimizing visualization of the left ventricle during systole and diastole. Obtain a second clip optimizing
visualization of the left atrium throughout systole and diastole.
o Properly align the image and capture the left atrium in full. Avoid any foreshortening of the chamber.
End Systole
•
End Diastole
C.1.iii. Color Flow Doppler for Mitral Regurgitation
Adjust color Doppler sample sector over the mitral valve and include the entire LA cavity. To optimize frame rate,
keep the color sector scan as narrow as possible, while including the entire LA. The color Nyquist limit is set at 64
cm/s in the HCHS/SOL protocol and should not be altered.
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 21 of 31
•
•
C.1.v. Spectral Doppler of Mitral Inflow
From the apical four chamber view record the mitral inflow velocity curve with the pulsed-wave Doppler sample
volume positioned at the tips of the mitral leaflets during quiet respiration for 30 seconds (or at least five cardiac
cycles). Adjust the baseline and Doppler scale to visualize the peak E and A wave velocities. Record a minimum of 3
cardiac cycles (10 for subjects in atrial fibrillation) at a sweep speed of 100 mm/sec.
C.1.vi. CW Doppler of the Mitral Regurgitation
Position the interrogation line as parallel to the flow as possible. Adjust the baseline and scale to capture the peak
MR velocity. Record a minimum of 3 cardiac cycles (10 for subjects in atrial fibrillation) at a sweep speed of 100
mm/sec.
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 22 of 31
C.1.iv. Tissue Doppler Imaging (TDI) of Mitral Annulus (lateral and septal)
1.
2.
3.
4.
5.
6.
7.
8.
9.
Decrease image depth (to include the LV and a small part of the LA, ideal depth approximately 16 cm) and optimize the
2D image for the LV, focusing on the lateral wall and the mitral annular region.
Adjust the image to orient the motion of the lateral wall parallel to the cursor. Both gains and filter settings should be set
low (100 Hz or less) to obtain the best images.
Initiate 2D color DTI and position the sample volume on the ventricular side of the lateral mitral annulus at the junction of
the LV wall with the mitral annulus of the lateral myocardial segment; the myocardium should stay within the sample
volume for as much of the cardiac cycle as possible.
Before the data is acquired, check that only the region to be sampled is moving through the sample volume.
Switch to PW spectral DTI and set the scale to 20 cm/sec with a sweep speed of 100 mm/sec.
Before collecting data, set the Pulsed Doppler velocity range to avoid velocity aliasing (a velocity range of +/- 24 cm/sec is
normal though subjects with high heart rates may require a higher setting).
Once a clear pattern is obtained, record at least 10-20 beats during quiet respiration (or preferably during breath holding
at end-expiration).
Record a minimum of 3 cardiac cycles (10 for subjects in atrial fibrillation) at a sweep speed of 100 mm/sec.
Repeat this process for the septal mitral annulus
Proper positioning of sample volume for mitral annular TDI:
Lateral
Septal
Tissue Doppler imaging at the lateral mitral annulus
Tissue Doppler imaging at the septal mitral annulus
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 23 of 31
C.2. Apical 4-Chamber View (Focused on the Right Ventricle)
In the ideal echocardiographic “window” for the Apical 4-Chamber View focused on the right ventricle:
•
The right ventricular length is maximized and the right ventricular apex is clearly visualized. The entire RV endocardium must
be within the sector scan in both end-diastole and end-systole.
End Systole
•
End Diastole
C.2.i. Color Doppler of tricuspid inflow
Adjust color Doppler sample sector over the tricuspid valve and include the entire RA cavity. The color Nyquist limit is
set at 64 cm/s in the HCHS/SOL protocol and should not be altered.
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 24 of 31
C.2.ii. CW Doppler of Tricuspid Regurgitation
•
Position the interrogation line down the right ventricle and atrium as parallel to tricuspid regurgitant flow as possible. Adjust the
baseline and scale to capture the peak TR velocity. Record at least 3 (10 for subjects in atrial fibrillation) full representative
systoles at sweep speed of 100 mm/sec.
C.2. iii. Tissue Doppler imaging at the lateral tricuspid annulus
•
•
•
•
•
Decrease image depth to include the RV and a small part of the RA (optimal depth approximately 16 cm) and optimize the 2D
image for the RV, focusing on the tricuspid annular region.
Adjust the image to orient the motion of the anterior tricuspid annulus parallel to the cursor. Both gains and filter settings
should be set low to obtain the best images.
Initiate 2D color DTI and position the sample volume on the ventricular side of the lateral tricuspid annulus at the junction of
the RV wall with the tricuspid annulus: the myocardium should stay within the sample volume for as much of the cardiac cycle
as possible.
Switch to PW spectral DTI and set the scale to 20 cm/sec with a sweep speed of 100 mm/sec. Once a clear pattern is
obtained, record at least 10-20 beats during quiet respiration (or preferably during breath holding at end-expiration).
Record a minimum of 3 cardiac cycles (10 for subjects in atrial fibrillation) at a sweep speed of 100 mm/sec.
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 25 of 31
C.2. iv. TAPSE imaging at the lateral tricuspid annulus
•
•
Switch to M-mode to record tricuspid annular plane systolic excursion
Ensure that M-mode cursor remains on axis with movement of the lateral tricuspid annulus
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 26 of 31
C.3. Apical 5-Chamber View
In the ideal echocardiographic “window” for the Apical 5-Chamber View:
•
Maximize LV length, making sure not to truncate the true long axis.
Apical 5 Chamber View
Apical 5 Chamber View with Color Doppler
C.3.i. Pulsed wave Doppler at the left ventricular outflow tract
•
For pulse wave acquisition, ensure that the sample is in the left ventricular outflow tract (LVOT) approaching the
aortic valve, just prior to the level of flow acceleration and spectral broadening. Record a minimum of 3 cardiac
cycles (10 for subjects in atrial fibrillation) at a sweep speed of 100 mm/sec.
C.3.ii. Continuous wave Doppler across the aortic valve
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 27 of 31
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 28 of 31
C.4. Apical 2-Chamber View
•
Obtain 1 clip optimizing visualization of the left ventricle during systole and diastole.
• Maximize LV length and be careful not truncate the true long axis.
• The scan plane transects the anterior and inferior LV walls, with neither the RV nor the LV outflow tract visualized.
• The most difficult areas in which to visualize the endocardium are usually the anterior LV wall and the apex; pay
particular attention to these walls. Visualization of both anterior and inferior wall endocardium will be essential to
accurately calculate left ventricular volume by Simpson’s formula.
• Adjust sector width and imaging depth to ensure acquisition frame rate of 50 to 70 frames per second.
End Systole
•
End Diastole
Obtain a second clip optimizing visualization of the left atrium throughout systole and diastole.
• Special attention should be paid to properly aligning the image and capturing the left atrium in full. Avoid any
foreshortening of the chamber.
End Systole
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
End Systole
Page 29 of 31
C.5. Apical Three Chamber View:
• Obtain a 2D image, including the entire LA and LV and mitral valve
•
Apical 3 Chamber view
D. Sub-costal View
This view is obtained from the sub-xiphoid position with the transducer manipulated to visualize the proximal inferior vena cava where it
meets the right atrium. Approximately 5-10 beats should be acquired in this view to allow for assessment of both IVC size and
compressibility with respiration.
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 30 of 31
X. Reporting of Critical Results
Sonographers performing echocardiographic studies will occasionally identify abnormalities that they consider important and will alert
site investigators directly. These findings will include, but are not limited to, tamponade, aortic dissection, thrombosed or frankly
dysfunctional prosthetic valve, pseudoaneurysm, intracardiac abscess or obvious vegetation, and intracardiac thrombus. The
Echocardiography Reading Center will also be informed via a “critical alert” checkbox and a free text field in the electronic
Echocardiography Transmittal Form (ETF) to facilitate an expedited analysis of the study. Site investigators will be responsible for
handling alert findings (either as alerts requiring emergency/immediate referral, urgent referral, or routine referral as they deem
appropriate), including relaying findings to study participant and, where consent has been provided, to the participant’s treating
provider.
Over-reading cardiologists at the Echocardiography Reading Center may identify critical abnormalities that would require emergent
notification and arrangements for care. Such findings will be reported within 24 hours of review by the Reading Center to the Data
Coordinating Center and will be communicated to the field centers as an Immediate Alert Notification. Abnormalities that would trigger a
critical result include, but are not limited to a) tamponade, b) aortic dissection, c) thrombosed or frankly dysfunctional prosthetic valve,
d) pseudoaneurysm, e) intracardiac abscess or obvious vegetation, f) intracardiac thrombus. Each field center should have a plan for
handling these types of alerts, including relaying findings to study participant and, where consent has been provided, to the participant’s
treating provider.
Over-reading cardiologists at the Echocardiography Reading Center may identify specific non-critical abnormalities that would be
important for a patient and physician to be aware of, but that don’t necessarily require emergent care. These findings will be
incorporated into the routine data transfers from the Echocardiography Reading Center directly to the Data Coordinating Center. Such
findings include: a) moderate or greater mitral regurgitation, b) moderate or greater mitral stenosis, c) moderate or greater obstructive
lesions of left ventricular outflow, including aortic stenosis and dynamic left ventricular outflow tract obstruction, d) moderate or greater
aortic regurgitation, e) moderate to severe pulmonary hypertension, f) severe right ventricular enlargement.
Limited quantitative data will be included in the routine reporting letter generated by the data coordinating center for all participants.
This will include three commonly used measures of cardiac structure and function: a) left ventricular ejection fraction, b) left ventricular
diastolic diameter, c) left ventricular wall thickness. These data will be presented in a table with reference values (see example below).
Values that exceed the reference thresholds would represent routine referrals as defined in section X. (Study Results Reporting
Schedule) of this document. Reference values are based on practice guidelines published by the American Society of
1
Echocardiography.
XI. Contact Information
For technical echo-related questions, please direct all questions and inquiries to the Brigham and Women’s Hospital Cardiac Imaging
Core Lab:
Project Coordinator:
Keri Schoonerman
Telephone:
1-617-525-6730
Fax:
1-617-582-6027
Email:
[email protected]
HCHS/SOL Echocardiographic Imaging Core Laboratory
PBB Ground Rm A-100
20 Shattuck Street
Boston, MA 02115
1
Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer
KT, Sutton MS, Stewart WJ. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and
Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a
branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005;18(12):1440-63.
DRAFT DOCUMENT- CONFIDENTIALHCHS/SOL Visit 2. Echo Field Center Manual of Operations
Page 31 of 31
File Type | application/pdf |
File Title | Protocol template |
Author | Andrew Satlin |
File Modified | 2014-06-23 |
File Created | 2014-06-23 |